First Percutaneous Lifelong RV Support

Right ventricular (RV) dysfunction is a life-threatening condition, leaving patients with right-sided heart failure with few—if any—truly effective treatment options. Current minimally invasive solutions offer only temporary relief, often leading to prolonged, incomplete recoveries, while long-term support demands high-risk, major surgery.

In Europe and the United States alone, nearly 3 million people live with right heart dysfunction. For 150,000 to 300,000 of them—those with end-stage heart failure (5–10%)—RV support is not just beneficial but essential. RV dysfunction typically stems from increased RV afterload, and 65% of these patients also suffer from severe tricuspid regurgitation. Yet, existing treatments are inadequate: 50% are ineligible for tricuspid therapy due to anatomical limitations, 20% fail to respond because of advanced disease, and 35% lack severe tricuspid regurgitation altogether.

The need for innovation has never been more urgent. Brightflow has risen to this challenge, receiving EMA Orphan Device designation (OD/EMA/EX/0000281308) for the treatment of isolated RV dysfunction and Fontan circulation failure, directly addressing this critical unmet clinical need.